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FDA 510(k) Applications Submitted by Bios s.r.l.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K072344
08/21/2007
APL MEDICAL SYSTEM
BIOS S.R.L.
K080374
02/12/2008
BIOSYAG MEDICAL SYSTEM
BIOS S.R.L.
K043521
12/20/2004
BIOSYAG 50 MED
BIOS S.R.L.
K210867
03/23/2021
NuEra Tight RF, NuEra Tight RF Plus
BIOS s.r.l.
K223856
12/23/2022
NuEra Tight RF Family
BIOS s.r.l.
K223907
12/28/2022
NuEra Tight RF Model APMD145.M70-US
BIOS s.r.l.
K200359
02/13/2020
NuEra Tight, NuEra Tight EMS
Bios s.r.l.
K201239
05/07/2020
NuEra Tight Family, EMS Model
Bios s.r.l.
K151296
05/15/2015
Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
BIOS S.R.L.
K161632
06/13/2016
FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)
BIOS S.R.L.
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